510(k) · Cleared
ClearedUniplate Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Feb 4, 2010 as substantially equivalent to K042544 (Depuy Spine, Inc., 2004) and 2 other predicates after a 24-day review. Its family tree reaches back 3 generations to 1997. 47 later devices descend from it.
- Decided
- Feb 4, 2010
- Review
- 24 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K971730 (1997). 5 ancestors in all, the oldest K914362 (1992). 47 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK971730 Depuy Motech Peak Polyaxial Anterior Cervical Plate SystemDepuy, Inc. · 1997
- 2 generations backK040197 Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
- 1 generation backK082273 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2008
- This deviceK100070 Uniplate Anterior Cervical Plate SystemDepuy Spine, Inc. · 2010
- Descendant · cites it directly · 21 of its ownK121514 Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012
- Descendant · 2 generations on · 18 of its ownK163104 Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017
- Descendant · 3 generations on · 15 of its ownK190016 Lateral Plate SystemCorelink, LLC · 2019
- Descendant · cites it directly · 11 of its ownK151553 Anterior Cervical Plate SystemOsteomed Implantes, Ltda · 2016
- Descendant · 4 generations on · 9 of its ownK203065 Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K121514Anodyne Anterior Cervical Plate SystemCorelink, LLC · 2012 · cites it directly21descendants
- K163104Terrace™ Anterior Cervical Plate SystemCorelink, LLC · 2017 · 2 generations on18descendants
- K190016Lateral Plate SystemCorelink, LLC · 2019 · 3 generations on15descendants
- K151553Anterior Cervical Plate SystemOsteomed Implantes, Ltda · 2016 · cites it directly11descendants
- K203065Lumbar Spine Truss System Plating Solution (LSTS-PS)4Web, Inc. · 2021 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971730 | Depuy Motech Peak Polyaxial Anterior Cervical Plate System | Depuy, Inc. | 1997 | — |
| −2 | K040197 | Eagle Anterior Cervial Plate System | Depuyacromed | 2004 | — |
| −1 | K082273 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2008 | — |
| 0 (this device) | K100070 | Uniplate Anterior Cervical Plate System | Depuy Spine, Inc. | 2010 | — |
| +1 | K121514 | Anodyne Anterior Cervical Plate System | Corelink, LLC | 2012 | — |
| +2 | K163104 | Terrace™ Anterior Cervical Plate System | Corelink, LLC | 2017 | — |
| +3 | K190016 | Lateral Plate System | Corelink, LLC | 2019 | — |
| +1 | K151553 | Anterior Cervical Plate System | Osteomed Implantes, Ltda | 2016 | — |
| +4 | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS) | 4Web, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042544 | Uniplate Anterior Cervical Plate SystemSummary page 1…roduct Code(s): KWQ Proprietary Name: UNIPLATE Anterior Cervical Plate System Predicate Devices: UNIPLATE Anterior Cervical Plate System (1(042544) UNIPLATE Anterior Cervical Plate System (K(082273) EAGLE Anterior Ce… | 2004 |
| * | K082273 | Uniplate Anterior Cervical Plate SystemSummary page 1…l Plate System Predicate Devices: UNIPLATE Anterior Cervical Plate System (1(042544) UNIPLATE Anterior Cervical Plate System (K(082273) EAGLE Anterior Cervical Plate System (K(040197) Device Description: The UNIPLATE Anterior… | 2008 |
| * | K040197 | Eagle Anterior Cervial Plate SystemSummary page 1…System (1(042544) UNIPLATE Anterior Cervical Plate System (K(082273) EAGLE Anterior Cervical Plate System (K(040197) Device Description: The UNIPLATE Anterior Cervical Plate System consists of an assortment o… | 2004 |
What descends from it? (47)
See all 4712 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121514 | Anodyne Anterior Cervical Plate System | 2012 | 21 |
| K151553 | Anterior Cervical Plate System | 2016 | 11 |
| K160702 | ZION Anterior Cervical Fixation System | 2016 | 3 |
| K132324 | Skyline Anterior Cervical Plate System, Uniplate Anterior Cervical Plate System… | 2013 | 3 |
| K132994 | Anodyne Anterior Cervical Plate System | 2013 | 1 |
| K192494 | NexGen Anterior Cervical Plate System | 2019 | 0 |
| K190170 | MVP Cervical Plate System | 2019 | 0 |
| K181471 | ACCUFUSE Cervical System | 2018 | 0 |
| K171439 | EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate… | 2017 | 0 |
| K162194 | MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K121514 (Corelink, LLC, 2012) has gone furthest, with 21 descendants of its own.
- 25 other devices also cite its predicate K042544.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The UNIPLATE Anterior Cervical Plate System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2-T1.
Indications include symptomatic cervical spondylosis, trauma, fracture, post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, re-operation for failed fusion, or instability following surgery for the above indications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K100070: Uniplate Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K100070
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026